Assessment of the Efficacy of the Dynamic Decongestive System in the Intensive Phase of Lower Limb Lymphedema
Condition(s) studied
Investigational drug(s) / intervention(s)
Control group: Traditional multicomponent bandages: In the control group, patients will wear traditional multicomponent bandages as a compression therapy modality 24/24 during the first 5 days of intensive treatment
DDS group: Dynamic compression device (DDS): Patients in the DDS group will wera the inverventional dynamic compression device as a compression modality 24/24 during the first five days of inpatient intensive treatment.
Study summary
The goal of this study is to compare the efficacy of a dynamic compression device (DDS) with traditional multicomponent bandages (TMCB) in terms of excess volume reduction in lower limb lymphoedema during the first 5 days of intensive treatment.
Participants in both groups will undergo the standard decongestive treatment protocol of the trial site. The only difference between both groups will be the modality of the compression therapy:
* the intervention (DDS) group will wear the compression 24/24 during the first 5 days of intensive treatment
* the control group will wear TMCB 24/24 during the first 5 days of intensive treatment (i.e. the standard treatment)
Eligibility
Primary outcome measure(s)
- Relative excess limb volume (%) during intensive treatment — 5 days
The primary outcome is the relative excess limb volume reduction (percent change) during the first 5 days of intensive treatment. Relative excess volume (%) will be calculated from serial limb volume measurements obtained once or twice daily, according to the number of bandage applications in each center's standard protocol, and expressed as the percentage reduction from baseline. This percentage change will be compared between the two treatment groups, with higher percentage reduction indicating a better decongestive outcome.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| CHU Montpellier - Saint Eloi | Montpellier | France | |
| CHU Toulouse - Rangueil | Toulouse | France | |
| Lympho-Opt Fachklinik fur Lymphologie | Pommelsbrunn | Bavaria |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07622615 on ClinicalTrials.gov ↗ ← All trials in France